Will Tevimbra become the 1st reimbursed immunooncology drug?

In esophageal squamous cell carcinoma in Korea?

BeiGene Korea starts drug pricing negotiations with the NHIS

Promised to provide the drug at a reasonable drug price and launch patient support programs

Will the first immuno-oncology treatment option in the field of esophageal cancer finally be born in Korea?

 

BeiGene Korea's immuno-oncology drug Tevimbra (tiselizumab), which passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review last month, has entered into drug price negotiations with the National Health Insurance Service for insurance reimbursement.

 

This comes about half a year after the drug passed the Cancer Disease Deliberation Committee review in August 2024 after a reattempt.

 

Tevimbra is a PD-1 inhibitory immuno-oncology drug that has demonstrated clinical utility in second-line esophageal squamous cell carcinoma and was approved in Korea in November last year.

 

Currently, there are seven immuno-oncology drugs approved and marketed in Korea: ▲Keytruda, ▲ Opdivo, ▲Tecentriq, ▲Imfinzi, ▲Bavencio, ▲Jemperli, and ▲Tevimbra, which have 64 indications.

 

However, only 21 therapies (about 33%) are currently listed for reimbursement.

 

None of these drugs are yet on the reimbursement list for esophageal cancer.

 

Currently, only platinum-based chemotherapy is reimbursed in Korea as both first-line and second-line treatment options for esophageal squamous cell carcinoma.

 

Reimbursement rates for immuno-oncology drugs by indication, including esophageal cancer, are low due to drug prices and national health insurance finances.

 

Since the drugs were reimbursed for some cancers, such as lung cancer, the overall claims of immuno-oncology drugs and their share in health insurance finance expenditures have increased significantly, raising Korea’s financial burden.

 

As of 2023, the total claims for anti-cancer drugs reached KRW 2.4 trillion, while claims for immuno-oncology drugs were KRW 500 billion, accounting for 20% of the total claims for anti-cancer drugs.

 

This is why the industry is welcoming the news of BeiGene's initiation of drug price negotiations for Tevimbra, as the company has announced its intention to supply the drug at a relatively low price.

 

BeiGene’s philosophy of providing “innovative new medicines at affordable prices” and eliminating underserved patients has already been demonstrated through the reimbursement process for its blood cancer drug Brukinsa (zanubrutinib).

 

The company has also made Tevimbra available at no cost to select esophageal cancer patients through its compassionate use program (EAP, Expanded Access Program).

 

It remains to be seen if Tevimbra will make it onto the reimbursement list after completing discussions with the Pharmacoeceonic Evaluation Subcommittee, Risk Sharing Subcommittee, and Drug Reimbursement Evaluation Committee.

 

Tevimbra extended the median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs.

 

6.3 months) in the global Phase III RATIONALE-302 trial, statistically significantly reducing the risk of death by 30%.

 

In the trial, Tevimbra demonstrated more than a twofold increase in the proportion of patients who responded to treatment compared to chemotherapy (20% vs.

 

10%), and the median duration of response was extended by about 3 months from 4.0 months to 7.1 months, showing a sustained response.

 

Based on such results, the U.S.

 

National Comprehensive Cancer Network (NCCN) recommended Tevimbra as a preferred option for the second-line treatment of esophageal squamous cell carcinoma at a high level (Category 1) in its revised treatment guidelines.